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Disturbed Sleep Model Study.

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00440323
First Posted: February 27, 2007
Last Update Posted: August 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
  Purpose
Subjects will be screened within 28 days. Each treatment session will consist of 2 PSG nights, study drug administration and noise model is conducted on second night.

Condition Intervention Phase
Sleep Initiation and Maintenance Disorders Drug: SB-649868 Drug: Zolpidem Drug: Placebo Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Primary Purpose: Treatment
Official Title: A Double-blind, Double-dummy, Randomised, Placebo-controlled,Four-way Crossover Study to Investigate the Effect of Single Oral Doses of SB-649868 and of Zolpidem in a Model of Noise Induced Situational Insomnia in Healthy Male Volunteers.

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Total Sleep Time measured overnight across four treatment sessions (4 weeks) [ Time Frame: 4 weeks ]

Secondary Outcome Measures:
  • The effects on daytime cognitive function following dosing across four treatment sessions (4 weeks) [ Time Frame: 4 weeks ]

Enrollment: 52
Actual Study Start Date: January 5, 2007
Study Completion Date: July 3, 2007
Primary Completion Date: July 3, 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ADBC sequence
In ADBC sequence A is Placebo, B is SB-649868 10 milligram (mg), C is SB-649868 30 mg, and D is Zolpidem 10 mg. Subject will receive placebo tablets, then two 5 mg tablets of SB-649868, then 25 mg and 5 mg tablet of SB-649868. There will be wash-out period of 7 days.
Drug: SB-649868
SB-649868 tablets will be available with dose strength of 5 and 25 mg.
Drug: Zolpidem
Zolpidem capsules will be available with dose strength of 10 mg.
Other Name: SB-649868
Drug: Placebo
Placebo tablet matching SB-649868 or Placebo capsule matching Zolpidem will be available.
Experimental: BACD sequence
In BACD sequence subject will receive SB-649868 two tablets of 5 mg each (10 mg, B), Placebo tablets (A), SB-649868 two tablets of 25 mg and 5 mg (30 mg, C), and Zolpidem 10 mg (D). There will be wash-out period of 7 days.
Drug: SB-649868
SB-649868 tablets will be available with dose strength of 5 and 25 mg.
Drug: Zolpidem
Zolpidem capsules will be available with dose strength of 10 mg.
Other Name: SB-649868
Drug: Placebo
Placebo tablet matching SB-649868 or Placebo capsule matching Zolpidem will be available.
Experimental: CBDA sequence
In CBDA sequence subject will receive SB-649868 two tablets of 25 mg and 5 mg (30 mg, C), SB-649868 two tablets of 5 mg each (10 mg, B), Zolpidem 10 mg (D) and Placebo tablet (A). There will be wash-out period of 7 days.
Drug: SB-649868
SB-649868 tablets will be available with dose strength of 5 and 25 mg.
Drug: Zolpidem
Zolpidem capsules will be available with dose strength of 10 mg.
Other Name: SB-649868
Drug: Placebo
Placebo tablet matching SB-649868 or Placebo capsule matching Zolpidem will be available.
Experimental: DCAB sequence
In DCAB sequence subject will receive Zolpidem 10 mg (D), SB-649868 two tablets of 25 mg and 5 mg (30 mg, C), Placebo tablet (A), and SB-649868 two tablets of 5 mg each (10 mg, B). There will be wash-out period of 7 days.
Drug: SB-649868
SB-649868 tablets will be available with dose strength of 5 and 25 mg.
Drug: Zolpidem
Zolpidem capsules will be available with dose strength of 10 mg.
Other Name: SB-649868
Drug: Placebo
Placebo tablet matching SB-649868 or Placebo capsule matching Zolpidem will be available.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Body weight =50 kg and BMI within the range 18.5-29.9 kg/m2 inclusive
  • Healthy as judged by responsible physician.
  • No clinically significant abnormality identified on the medical or laboratory evaluation and 12-lead ECG;
  • The subject shows a normal sleep pattern on the basis of the evaluation of both PSG screening nights. Normal sleep will be defined as follows: LPS (Latency to persistence Sleep) <30min., SE (Sleep Efficiency) >85%, apnea/ hypopnea index < 10, periodic leg movements (PLM) with arousal index < 10. The apnea/hypopnea index is defined as "the number of apneas and hyponeas divided by the total sleep time (TST) expressed in hours". PLMI is defined as "the number of periodic leg movements associated with arousals or awakening divided by the total sleep time (TST) expressed in hour".

Exclusion Criteria:

  • A positive result for the pre-study urine drug/ alcohol breath screen.
  • Abuse of alcohol.
  • Subject complains of sleep disturbances and /or is receiving treatment for sleep disorders.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00440323


Locations
United Kingdom
GSK Investigational Site
Guildford, Surrey, United Kingdom, GU2 7XP
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00440323     History of Changes
Other Study ID Numbers: OXS104094
First Submitted: February 23, 2007
First Posted: February 27, 2007
Last Update Posted: August 17, 2017
Last Verified: August 2017

Keywords provided by GlaxoSmithKline:
Noise induced Situational insomnia,
healthy volunteers
SB-649868,
Zolpidem,

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders
Zolpidem
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
GABA-A Receptor Agonists
GABA Agonists
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action